A Phase 2 interventional study of Motivational Interview in Heart Disease, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-24.
Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment
The purpose of this research study is to survey patients to learn about their beliefs and behaviors related to the management of heart disease and to discuss options for making healthy lifestyle changes. From the information the investigators get from patients, the investigators hope to develop better methods for taking care of patients who have heart disease.
Coronary heart disease (CHD) is a significant health threat among veterans. Compared to their civilian counterparts, veterans experience greater disability, reinfarction, and mortality following myocardial infarction (MI) and other acute coronary syndromes (ACS). High rates of hypertension, diabetes, and cardiac risk behaviors (e.g., smoking) and low socioeconomic status (SES) further increase veterans' CHD-related morbidity and mortality. The proposed pilot project will establish the feasibility of a telehealth nursing intervention for veterans with CHD who are recovering from MI/ACS. The Veterans Heart Attack Representations Telehealth (Vet-HART) intervention is designed to promote adaptive conceptual change in veterans' beliefs (common sense models or representations) about CHD etiology and self-management and facilitate health behavior changes (e.g., smoking cessation, medication adherence, diet management, and increased physical activity). The long-term goal of this research program is to improve veterans' quality of life (QoL) and reduce their CHD-related morbidity/mortality. The proposed project is the requisite next step in attaining that goal.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
Behavioral: Motivational Interview
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
SF-36v Physical Function Scale
Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
SF-36v Role Limitations Due to Physical Health Scale
Role Limitations Due to Physical Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
SF-36v Role Limitations Due to Emotional Problems Scale
Role Limitations Due to Emotional Problems Scale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
SF-36v Energy-Fatigue Scale
Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
SF-36v Emotional Well-Being Scale
Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
SF-36v Social Functioning Scale
Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
SF-36v Pain Scale
Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
SF-36v General Health Scale
General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Physical Limitations Scale
Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Angina Stability Scale
Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Angina Frequency Scale
Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Treatment Satisfaction Scale
Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
Seattle Angina Questionnaire Disease Perception Scale
Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
Time frame: Change from baseline to 3-months post hospital discharge
| Milestone | Motivational Interview | Usual Care |
|---|---|---|
| Started | 6 | 6 |
| Completed | 3 | 6 |
| Not completed | 3 | 0 |
| Withdrew: Lost to follow-up | 3 | 0 |
Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| SF-36v Physical Function Scale | -6.67 ± 7.64 | 13.33 ± 12.52 |
Role Limitations Due to Physical Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| SF-36v Role Limitations Due to Physical Health Scale | -22.92 ± 35.54 | 9.38 ± 36.39 |
Role Limitations Due to Emotional Problems Scale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| SF-36v Role Limitations Due to Emotional Problems Scale | -27.78 ± 25.46 | 5.56 ± 13.61 |
Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| SF-36v Energy-Fatigue Scale | -5.00 ± 42.65 | 1.67 ± 23.49 |
Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| SF-36v Emotional Well-Being Scale | -14.67 ± 37.86 | -2.00 ± 7.90 |
Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| SF-36v Social Functioning Scale | -16.67 ± 40.18 | -10.42 ± 18.40 |
Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| SF-36v Pain Scale | -5.00 ± 13.23 | 14.17 ± 13.10 |
General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| SF-36v General Health Scale | -5.00 ± 18.03 | 4.17 ± 17.15 |
Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| Seattle Angina Questionnaire Physical Limitations Scale | -5.93 ± 8.98 | 3.33 ± 30.43 |
Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| Seattle Angina Questionnaire Angina Stability Scale | 25.00 ± 66.14 | -12.50 ± 17.68 |
Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| Seattle Angina Questionnaire Angina Frequency Scale | 20.00 ± 43.59 | 16.67 ± 22.51 |
Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| Seattle Angina Questionnaire Treatment Satisfaction Scale | -3.92 ± 33.45 | 7.84 ± 10.95 |
Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
| units on a scale | Motivational Interview | Usual Care |
|---|---|---|
| Seattle Angina Questionnaire Disease Perception Scale | 13.89 ± 9.62 | 9.72 ± 17.01 |
Collected over 3 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Motivational Interview | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Usual Care | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(Years) | Motivational Interview | Usual Care | Total |
|---|---|---|---|
| Mean | 68.33 ± 11.98 | 65.67 ± 8.64 | 67.00 ± 10.05 |
| Sex: Female, Male(Participants) | Motivational Interview | Usual Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 6 | 6 | 12 |
| Race (NIH/OMB)(Participants) | Motivational Interview | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 1 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 5 | 8 |
| Region of Enrollment(participants) | Motivational Interview | Usual Care | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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